A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System

Central Nervous System Infection Clinical Trial

Official title:

A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03960905
• Other study ID #: 2019-CNSI-001
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: Shandong University
• Contact: Zhao Wei, Ph.D
• Phone: 053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.

Description:

The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children (29 days-18 years old) with anti-infective therapy against infectious disease in central nervous system.

• Clinical symptoms: acute onset, fever (axillary temperature 38 ? or higher), headache, altered level of consciousness, vomiting, irritability, sleepiness, low muscle tone, seizures, before the fontanelle full or uplift, positive meningeal stimulation;

• Aboratory examination: CSF appearance change, CSF routine WBC >100 per ml, CSF routine WBC 10-100 per ml, glucose <40mg/dl, protein >100mg/dl), positive detection of etiology (bacterial culture, antigen detection, gram staining).

Exclusion Criteria:

• autoimmune encephalitis;

• central nervous system infection complicated with tumor;

• allergic to carbapenems or glycopeptide antibiotics;

• other cases not suitable for enrollment (small sample size, incomplete clinical data, etc.).

Related Conditions & MeSH terms

• Central Nervous System Infection
• Central Nervous System Infections
• Communicable Diseases
• Infection

Intervention

Other:
• Children with the usage of anti-infective drugs
According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.

Locations

Country	Name	City	State
China	Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Wei Zhao	Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum concentration (Cmax)	Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.	up to 4 weeks
Secondary	time to achieve maximum concentration (Tmax)	Tmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed.	up to 4 weeks